New federal agency to authorise drugs, medical devices

Swissmedic will start its operations on January 1 next year Keystone

The Swiss authorities have established a new federal agency responsible for pharmaceuticals. Swissmedic will be officially launched at the beginning of next year, when a new law on therapeutic substances goes into effect.

Swissmedic will issue authorisations for new medicines as well as medical devices. It will also keep an eye on the pharmaceuticals market, and companies and production techniques will come under its scrutiny.

The new organisation will be the result of the merger of the Federal Health Office’s therapeutic agents’ unit and the inter-cantonal pharmaceutical control office.

The authorities hope the new entity will become an international leader in its field. The government would like Swissmedic to be a reference for market surveillance.

The organisation has four years to establish its credentials, at a cost of SFr49 million ($30.4 million) per year. The government will pay out SFr21 million, with the rest coming from fees and taxes.

The law on therapeutic agents will simplify the import of medical products. Imports of pharmaceuticals no longer protected by a patent will be allowed as long as their price is cheaper than the going rate on the Swiss market and they fulfil safety criteria.

swissinfo with agencies